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Cannabinoid

Dronabinol for Postoperative Pain (dronabinol Trial)

Phase 3

Recruiting

Led By Jason M Jennings, MD DPT

Research Sponsored by Colorado Joint Replacement

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 21-75

Male or Female aged 21-75

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks and 6 weeks post operative

Awards & highlights

dronabinol Trial Summary

This trial found that preoperative medical cannabis use was associated with less postoperative narcotic use.

Who is the study for?

This trial is for adults aged 21-75 undergoing knee replacement at Colorado Joint Replacement who can take oral meds and follow the study plan. They must not have used narcotics in the last 6 weeks, cannabis regularly in the past 3 months, or tobacco recently. No history of major mental disorders, seizures, drug/alcohol abuse, or allergies to dronabinol.Check my eligibility

What is being tested?

The trial tests if Dronabinol reduces painkiller needs after knee surgery compared to a placebo. Participants are randomly assigned to receive either Dronabinol or a placebo and their narcotic consumption post-surgery is monitored.See study design

What are the potential side effects?

Dronabinol may cause dizziness, mood changes, weakness, lack of coordination; it might also affect blood pressure and heart rate. The side effects vary from person to person.

dronabinol Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 75 years old.

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I am between 21 and 75 years old.

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I am having a knee replacement at Colorado Joint Replacement.

dronabinol Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks and 6 weeks post operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks and 6 weeks post operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks and 6 weeks post operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Morphine Equivalence

Secondary outcome measures

Defense and Veterans Pain Scale

KOOS-12 Knee Survey

Knee Society Score

+3 more

dronabinol Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: dronabinolExperimental Treatment1 Intervention

Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.

Group II: placeboPlacebo Group1 Intervention

Patient will be directed to take 2.5mg of Study Drug 2 times a day for 4 weeks. Patient is blinded as to whether or not this is Dronabinol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dronabinol

FDA approved

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Colorado Joint ReplacementLead Sponsor

11 Previous Clinical Trials

2,761 Total Patients Enrolled

4 Trials studying Osteoarthritis

619 Patients Enrolled for Osteoarthritis

Jason M Jennings, MD DPTPrincipal InvestigatorColorado Joint Replacement

1 Previous Clinical Trials

496 Total Patients Enrolled

1 Trials studying Osteoarthritis

496 Patients Enrolled for Osteoarthritis

Media Library

Dronabinol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04298528 — Phase 3

Osteoarthritis Research Study Groups: dronabinol, placebo

Osteoarthritis Clinical Trial 2023: Dronabinol Highlights & Side Effects. Trial Name: NCT04298528 — Phase 3

Dronabinol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04298528 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some possible dangers associated with Dronabinol?

"Dronabinol has been given a safety rating of 3 by our team at Power. This is because it is a Phase 3 trial, which means that there is not only some data supporting efficacy, but multiple rounds of data supporting safety."

Answered by AI

For what conditions is Dronabinol most commonly prescribed?

"The medication Dronabinol is not only used to help patients that are looking to lose weight, but can also be given to those who have failed other forms of therapy, or have lost their appetite."

Answered by AI

To whom does this study extend an invitation?

"From the ages of 21 to 75, this study is looking for patients that have had a knee replacement surgery at Colorado Joint Replacement. Furthermore, these individuals must be willing and able to comply with additional procedures, take oral medication, use contraception if they are of reproductive potential, and not currently use drugs including cannabis."

Answered by AI

What are some other examples of clinical trials that have used Dronabinol?

"Dronabinol is being researched in 44 different trials, 7 of which are in Phase 3. Many of these clinical studies are taking place in Belmont, Massachusetts; however, Dronabinol trials can be found at 113 locations globally."

Answered by AI

Are people currently able to sign up for this experiment?

"Yes, the information on clinicaltrials.gov point out that this trial is presently seeking candidates. The study was first posted on 2/5/2020 and was last updated on 8/2/2021. The study is looking for 460 participants at 1 locations."

Answered by AI

If a patient is below 35 years of age, would they be able to enroll in this clinical research?

"The current recruitment phase for this clinical trial is focused on patients that are between 21 and 75 years old."

Answered by AI

How many individuals are included in this test group?

"That is correct, the online information from clinicaltrials.gov does state that this study is recruiting patients as of right now. This trial was first posted on February 5th 2020 and has had one edit made on August 2nd 2021. The aim is to enroll 460 patients at a single location."

Answered by AI